§ 830.20. Requirements for a unique device identifier.
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/us/cfr/t21/s§ 830.20·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
A unique device identifier
(UDI)must:
(a)Be issued under a system operated by FDA or an FDA-accredited issuing agency;
(b)Conform to each of the following international standards:
(1)ISO/IEC 15459-2, which is incorporated by reference at § 830.10;
(2)ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and
(3)ISO/IEC 15459-6, which is incorporated by reference at § 830.10.
(c)Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10. [78 FR 58825, Sept. 24, 2013]
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§ 830.20
Requirements for a unique device identifier.
Fed. Reg.×2
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